Trident 542-11-60GRecalls & reported problems
Howmedica Osteonics Corp. · Cluster Acetabular Shell · Class 2 · Implant
All models of Trident (160)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540240538), received between Aug 13, 2018 and Jan 3, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Loss of Osseointegration1
- Unstable1
Patient problems
- Injury2
- Inadequate Osseointegration1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 3, 2019Unstable; Unstable
PSL SHELL, IMPLANTED (B)(6) 2018, WAS IN A VERTICAL POSITION - HIP STABILITY NOT GOOD IN THAT POSITION. SURGEON REMOVED SHELL, SCREWS, LINER, HEAD, AND IMPLANTED NEW SHELL, SCREWS, LINER, HEAD. PATIENT STABLE. NO COMPLICATIONS.
Patient problems: Injury
MAUDE report 8214874 ↗InjuryAug 13, 2018Loss of Osseointegration; Loss of Osseointegration
AS REPORTED: "DOCTOR...INFORMED ME OF A PATIENT DONE AT ANOTHER HOSPITAL BY ANOTHER SURGEON THAT WAS REFERRED TO HIM BY THAT SURGEON. PATIENT COMPLAINT OF PAIN. "MRI AND BONE SCAN CONSISTENT WITH PARTICLE DISEASE". SURGERY IS SCHEDULED FOR (B)(6) 2018. NO OTHER INFORMATION IS AVAILABLE. DOCTOR DIDN'T TELL ME SIDE. ANOTHER PER WILL BE FILED...AFTER SURGERY". REP REPORTED THAT THIS EVENT IS FOR PATIENT'S HIP. UPDATE 23-JUL-2018: PATIENT REVISED ON (B)(6) 2018. AS REPORTED BY REP: "NECROTIC FAT AND SOME FLUID WAS ASPIRATED AFTER INCISION WAS MADE. FEMORAL STEM WAS WELL FIXED AND ANTEVERTED APPROPRIATELY. [SURGEON] THINKS THE CUP WAS LOOSE. REMOVED THE HEAD AND ACETABULUM ALONG WITH ONE SCREW. A [COMPETITOR] MULTIHOLE REVISION SHELL WAS INSERTED. A NEW FEMORAL HEAD WAS PLACED ON THE STEM. LEFT SIDE. NO OTHER INFORMATION IS AVAILABLE DUE TO HOSPITAL POLICY".
Patient problems: Inadequate Osseointegration; Injury; Pain
MAUDE report 7779600 ↗
Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices
- STAGEONE 431209Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 recalls0 reports
- SELF CENTERING 1035-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented84 reports
- LFIT 6260-9-036Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented80 reports
- ACTIS 101011060Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented66 reports
- RINGLOC BI-POLAR HIP SYSTEM 11-165228Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall1 death12 reports
- SELF CENTERING 1035-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented60 reports
- TANDEM 71324046Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented59 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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